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The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.
Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training set | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
|
| VERIFICATION SET | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training set | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
|
| Measure | Description | Time Frame |
|---|---|---|
| REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy. | We select patients affected by endometrial cancer and benign endometrial disease. Preoperative they underwent to pelvic ultrasound, CA125 and HE4 dosage and anamnesis. They will be considered as training group to obtaine the probability of endometrial malignancy based on HE4, ultrasound features and symptoms. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| REM | We select a verification set, composed by endometrial cancer disease and benign endometrial pathologies patients. In this set we apply the risk of endometrial cancer tool, obtained in the training set, in order to verify the sensitivity, specificity and reproducibility. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| REM | We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Angioli, MD | Campus Biomedico University of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| campus bio-medico of Rome | Rome | 00128 | Italy |
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| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| VERIFICATION SET | Other | We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative |
|
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |